I have not encountered such a situation. This agreement looks wrong when we first look at it. As a result, it prevents an employee from working elsewhere. but I think this agreement is a good method. ...

Companies have to do business in other countries for many reasons. The two simplest examples of this are to sell products in that country or to produce in that country. Let's first examine the product...

We generally use the verbal agreement when dealing with mundane tasks in daily life. To give an example, when we call a plumber to the house, we make a verbal agreement for a low-budget job and expect...

First of all, while forming a team, I question whether each person I will choose has worked in that job, in that task before. If the people I will choose do not have any experience with these tasks, I...

The company I used to work for also had a matrix organization. While I was working with the product design in the R&D department, I was also helping the production department with their jig/fixtur...

In Functional Organization, it is both an advantage and a disadvantage that the decision is made by one person. In your opinion, what kind of arrangements can be made to turn this situation into just ...

As we learned in the lesson, risk management covers every aspect of the product. These stages are pre-market, product realization and, post market. therefore, every stage should be taken into consider...

If we notice the risks early, we can reduce the risk by making changes in the design. If we find out later, we can carry out a part/component design as a precautionary addition to this. If we do not h...

As we learned in the course this week, ISO 14971 is used for medical devices in the US, while ISO 13485 is used in Europe for risk management. And this ISO 13485 cites ISO 14971.Why do you think Europ...

First of all, the tests must comply with the regulations. If you do not manufacture a part of the product, and you have it done by another company, that company must comply with these regulations whil...

I don't know if there is a company that does this, but I don't think they will either. Because, no matter how little it is desired to give revisions within the company, after each document is produced...

Although we cannot say that these two documents are the same, we can say that they are similar to each other. While DID is a document prepared by marketing and contributed by other departments, DSD is...

In my opinion, the company will avoid it as overvalidation will be a cost to the company. If you provide more features than necessary, this will incur additional costs to the company and the product t...

The FDA primarily controls the documentation. It checks whether the documents are complete, whether they are filled in completely, whether the revisions that occur during the project are recorded. it ...

As forum members have mentioned before, design controls benefit both the company and the end user. This device produced by the company should be compatible with people and should not harm people. ther...